Packaged diagnostic electrode device



July 7, 1970 R. E. MAscN PACKAGED DIAGNOSTIC ELECTRODE DEVICE Filed Oct. l2, 1967 FIG.1

ROBERT E. MASON INVENTOR United States Patent 3,518,984 PACKAGED DIAGNOSTIC ELECTRODE DEVICE Robert E. Mason, Baltimore, Md., assignor to The Johns Hopkins University, a corporation of Maryland Filed Oct. 12, 1967, Ser. No. 674,970 Int. Cl. A61b 5/04 ABSTRACT F THE DISCLOSURE A prepared cardiograph type of electrode complete with electrode -paste as a one-use article of commerce is described. The electrode includes a conductive mesh member sandwiched centrally between non-conductive washers, with an insulated electric lead connected to the conductive mesh and passed out of the assembly through a tight-fitting permanent upper cover. The holes of the nonconductive washers and of a third perforated member below the sandwiching washers form a cavity |which contains electrode paste, immersing the conductive mesh member. The paste is retained by a sealing cover which is temporary and which additionally protects the pressure sensitive area of the device by which it is afiixed to the skin of a patient.

This invention relates generally to packaging devices, and more particularly it pertains to an electrode device complete with electrolyte as an article of commerce.

The medical trade is increasingly aware of the advantages of one-use disposable diagnostic devices. In my copending patent application, Ser. No. 558,316, filed J une 17, 1966 entitled Electrode Device, which application is now in allowance with the final fee paid, so that patent issuance is expected in due course, there is described an electrode for body attachment which in addition to possessing other desirable attributes can be manufactured so economically as to be a one-use article.

Another object of this invention is to provide an electrode for body attachment which is of very low mass and one which adheres tightly to the skin and which conducts solely through a layer of electrode paste, and one in which the electrode paste is in place in the device.

Another object of this invention is to provide an inexpensive one-use disposable electrode including electrode paste which provides uniform area of contact despite variations in the quantity of electrode paste used.

Still another object of this invention is to provide an electrocardiograph electrode including electrode paste in position which is free of casual metal-to-skin contact under Working stress of the patient to give reliablelEKG records free from baseline drift despite rapid respiration and sweating.

To save time and possible waste of material, it is an object of the present invention to include the proper charge of electrode paste already in place in the device with provision for safe handling and storage as Iwill be related.

lOther objects and attendant advantages of this invention will become more readily apparent and understood from the detailed specification and accompanying single sheet of drawings in which:

FIG. 1 is an exploded View of the components of a novel electrode encorporating features of this invention; and

FIG. 2 is a cross section of the electrode of FIG. 1 as assembled and ready for shipment.

Referring now to the figures of the drawings, reference number indicates generally an electrode. This electrode 10 comprises an assembly made up of two centrally apertured wafers 12 and 14 of very thin flexible plastic sheet.

A washer or collar 18 of flexible plastic approximately one-half mm. in thickness is centrally placed on the bottom wafer 14 and on top of this a -disc 16 of fine stainless steel wire cloth is centered. A fine flexible insulated wire 20 is soldered to the top of this disc 16 and brought up through the apertured top wafer 12 and the latter is then brought down over the assembly and welded or cemented to the bottom wafer 14. The underside of wafer 14 is coated with pressure sensitive adhesive 26.

A tight-fitting washer 11 of plastic is reeved over the -wire 20 and cemented to the Wafer 12 so as to cover the aperture thereof with a good margin. A measured charge of electrode paste 28 is then inserted through the lower apertured disc 24 so as to embed the disc 16. A temporary plastic disc .25, preferably having a waxed paper surfacing 24, is applied to the adhesive covering 26 of the disc 14 to protect the latter and to seal off the contained electrode paste 28 in the assembly.

This temporary disc 25 Iwith its -wax paper 24 will peel easily from the adhesive 26 when the electrode 10 is being placed in service and will allow the immediate afiixing to the skin of the patient by pressure.

Obviously many modifications and variations of the present invention are possible in light of the above teachings. It is, therefore, to be understood that within the scope of the appended claims the invention may be practiced otherwise than as specifically described.

What s claimed is:

1. As an article of manufacture, a diagnostic electrode of single use impregnated type, comprising, first and second centrally apertured non-metallic flexible elements, Iwith the outer edges thereof sealed together, a third centrally apertured non-metallic flexible element positioned between said first and second elements to space respective central portions of said first and second elements from each other, with the apertures of said first, second and third elements being in axial alignment with each other thereby together defining a space for containing electrode paste, a predetermined charge of electrode paste in Said space, rnetallic mesh material positioned between one of said first and `second elements and said third element and in electrical contact with said electrode paste, electrical lead means secured to said mesh material and passing through the aperture of one of said first and second elements, and closure means for closing the exposed faces of said first and second elements, thereby retaining the electrode paste in said space. p

2. A diagnostic electrode as recited in claim 1, wherein the other of said first and second elements has an adhesive on its exposed race, with the closure means for the other of said first and second elements being removably secured thereto and in contact with said electrode paste, whereby said-electrode paste is exposed for contact on removal of said removably secured closure means.

3. A diagnostic electrode as recited in claim 1, wherein said first and second elements consist of two centrally apertured wafers formed of thin flexible plastic sheet.

4. A diagnostic electrode as recited in claim 3, wherein said third element consists of a collar of greater thickness than said first and second elements, and wherein the thickness of said collar is interposed bet-Ween said metallic mesh material .and said removably secured closure means.

5. A diagnostic electrode as recited in claim 4, wherein said metallic mesh material consists of a fine stainless wire cloth.

6. A diagnostic electrode as recited in claim 5, wherein said electrode is of low mass, and has a uniform area of contact defined by a said element central aperture on removal of said removably secured closure means.

7. A diagnostic electrode of single use impregnated type, comprising, rst, second and third centrally apertured non-metallic exi-ble elements, said third centrally apertured non-metallic exib-le element being positioned and contained between said first and second elements to space said first and second elements from each other, with the apertures of said first, second and third elements being in axial alignment with each other, thereby defining a space for containing electrode paste, conductive mesh material means having a predetermined charge of electrode paste, said conductive mesh material means and electrode paste positioned in axial alignment with said apertures and spanning said apertures, signal means including an electrical lead secured to said conductive mesh material means, and closure means Ifor closing the apertures of the first and third exible elements.

i8. A diagnostic electrode as recited in claim 7, and additionally means including an adhesive positioned on the exposed face of the other of said first and second elements for removably securing its respective closure means thereto.

9. A diagnostic electrode of single use impregnated type, comprising: plural, apertured non-metallic spacer means, all said spacer means being flexible and all said apertures being aligned, mesh conductor means secured between plural of said spacer means across the apertures thereof, a predetermined charge of electrode paste positioned in said aligned apertures of said non-metallic spacer means in electrical contact with the mesh conductor means, signal means including an electrical lead secured to said mesh conductor means and extending to the exterior of the diagnostic electrode, and means for closing said aligned apertures of said non-metallic spacer means, thereby retaining the predetermined charge of electrode paste within the diagnostic electrode.

`10. A diagnostic electrode as recited in claim 9, wherein said closure means are removably mounted to said spaced means.

` References Cited UNITED STATES PATENTS WILLIAM E. KAMM, Primary Examiner U.S. C1. X.'R. 128-417 

